BioCardia Completes Clinical Consultation Process with Japan's PMDA for CardiAMP Cell Therapy System, Advancing Toward Submission of Marketing Approval Application

BioCardia targets its first patient treatments in Japan and commercial revenues in 2028, with regulatory review still required.

Rhea-AI Summary

BioCardia (NASDAQ: BCDA) completed consultations with Japan's Pharmaceuticals and Medical Devices Agency on application materials for its CardiAMP Cell Therapy System.

The consultations concern materials required to seek Japanese approval for treating ischemic heart failure. BioCardia said the completed work positions it to initiate the process toward final regulatory approval review. It targets treating its first patients in Japan and realizing commercial revenues in 2028.

CardiAMP is intended as a minimally invasive, catheter-based therapy using patients' own cells. It has been evaluated in three clinical trials involving more than 200 patient procedures, including two randomized, double-blind, placebo-controlled trials. The consultation milestone does not constitute regulatory approval; PMDA review and applicable Japanese regulatory requirements remain.

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0 major · 1 point

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointCardiAMP application-material consultations with Japan's PMDA are completed, advancing the regulatory process.
• Minor point. Forward-looking: it has not happened yet and may not happen.BioCardia targets 2028 for first patient treatments in Japan and commercial revenues.

Negative

• Minor pointCardiAMP remains subject to PMDA review and Japanese regulatory requirements; completed consultations do not constitute approval.

Key Figures

Clinical trials: 3 trials Patient procedures: More than 200 patient procedures Randomized, double-blind, placebo-controlled trials: 2 trials +1 more

Clinical trials

3 trials

CardiAMP evaluation

Patient procedures

More than 200 patient procedures

Across the three clinical trials

Randomized, double-blind, placebo-controlled trials

2 trials

Included in CardiAMP's clinical evaluation

Target for first Japan patients and commercial revenues

2028

Company target

Historical Context

1 past event · Latest: Sep 23

1 event

1. Sep 23

   PMDA submission update

   24h Move

   +0.0%

   Described preparation of the CardiAMP Japan Shonin submission after PMDA consultations, targeting a Q4 2026 filing.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

autologous, induced pluripotent stem, double-blind, placebo-controlled

4 terms

autologous medical

"a minimally invasive, catheter-based autologous cell therapy option"

Autologous describes a medical product or treatment made from a patient’s own cells or tissues rather than from a donor. For investors, autologous approaches matter because they can lower the risk of immune rejection and improve effectiveness, but they often require individualized manufacturing, complex logistics, and higher per-patient costs—factors that affect scalability, pricing, and regulatory hurdles in healthcare businesses.

induced pluripotent stem medical

"including induced pluripotent stem (iPS) cell therapies"

Cells that have been reprogrammed from a specialized adult cell back into a pluripotent state so they can divide and develop into many different cell types; this reprogramming is achieved by introducing specific factors or genes that reset the cell’s identity. Induced pluripotent stem cells behave like embryonic stem cells in their ability to generate a wide range of tissues, but they can retain genetic or epigenetic changes from their original donor cells and carry risks such as abnormal growth or tumor formation unless carefully controlled.

double-blind medical

"two randomized, double-blind, placebo-controlled trials"

A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.

placebo-controlled medical

"two randomized, double-blind, placebo-controlled trials"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

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SUNNYVALE, Calif., Nov. 06, 2026 (GLOBE NEWSWIRE) -- BioCardia®, Inc. (NASDAQ: BCDA), a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that it has completed the process with Japan's Pharmaceuticals and Medical Devices Agency (PMDA) concerning the application materials required to obtain regulatory approval in Japan for its CardiAMP Cell Therapy System ("CardiAMP") for the treatment of ischemic heart failure.

This milestone represents significant progress toward regulatory approval and commercialization of CardiAMP in Japan, one of the world's largest and most sophisticated cardiovascular medical device markets and a country at the forefront of regenerative medicine, including induced pluripotent stem (iPS) cell therapies.

"With the completion of consultations with PMDA regarding our application materials, we are closer to the day when we can provide CardiAMP cell therapy to heart failure patients in Japan," said Peter Altman, Ph.D., Chief Executive Officer of BioCardia. "The extensive work completed with PMDA positions us to initiate the process toward final regulatory approval review. We are targeting the treatment of our first patients in Japan and the realization of commercial revenues in 2028."

CardiAMP is intended to provide patients with ischemic heart failure a minimally invasive, catheter-based autologous cell therapy option. This patient population continues to have significant unmet medical needs despite advances in modern medical and device-based therapies. The therapy has been evaluated in three clinical trials involving more than 200 patient procedures, including two randomized, double-blind, placebo-controlled trials.

Completion of the consultation process does not constitute regulatory approval. The CardiAMP Cell Therapy System remains subject to PMDA review and applicable Japanese regulatory requirements.

About BioCardia

BioCardia, Inc., headquartered in Sunnyvale, California, is a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases. CardiAMP® autologous and CardiALLO™ allogeneic cell therapies are the Company's biotherapeutic platforms, with three cardiac clinical-stage product candidates in development. These therapies are enabled by its Helix™ biotherapeutic delivery and Morph® vascular navigation product platforms, and its Heart3D™ fusion imaging platform under development.

Forward-Looking Statements

This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, statements relating to the anticipated submission and potential marketing approval of the CardiAMP Cell Therapy System in Japan, the anticipated duration and outcome of regulatory review, potential reimbursement, commercialization, market opportunity, patient eligibility, and the timing of initial treatments and revenues.

These forward-looking statements are made as of the date of this press release.

Risk factors that could materially affect actual results can be found in BioCardia's Form 10-K filed with the Securities and Exchange Commission on March 24, 2026, under the caption "Risk Factors," and in its subsequently filed Quarterly Reports on Form 10-Q.

BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.

MEDIA CONTACT:
Miranda Peto, Investor Relations
mpeto@biocardia.com
(650) 226-0120

INVESTOR CONTACT:
David McClung, Chief Financial Officer
investors@biocardia.com
(650) 226-0120

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

Has BioCardia's CardiAMP received regulatory approval in Japan?

No. BioCardia completed consultations with PMDA concerning application materials, but that milestone does not constitute regulatory approval. CardiAMP remains subject to PMDA review and applicable Japanese regulatory requirements.

When does BioCardia expect CardiAMP treatments and commercial revenues in Japan?

BioCardia targets 2028 for treating its first patients in Japan and realizing commercial revenues. This is a company target, and CardiAMP still requires regulatory review.